Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test: Animals were treated for 4 hour using occlusive conditions. An application site of 2x2 cm was covered with the liquid test substance. After the application time (4 h) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 and 48 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylimidazole
EC Number:
211-765-7
EC Name:
2-methylimidazole
Cas Number:
693-98-1
Molecular formula:
C4H6N2
IUPAC Name:
2-methyl-1H-imidazole
Details on test material:
- Name of test material (as cited in study report): 2-Methylimidazol in Schuppen
- Substance no.: 77/697

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER (6050 Offenbach)
- Weight at study initiation: ca. 2.77 kg
- Diet: Sniff K, standard diet for rabbits and guinea pigs (Firma INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 80% aqueous preparation
Duration of treatment / exposure:
4 h
Observation period:
8 d
Number of animals:
6 (1 male, 5 females)
Details on study design:
TEST SITE
- Area of exposure: 2 x 2 cm
- Type of wrap:: rubberised linnencloth, fixed with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (50% or 100%) and dried with cellulose
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: time point 72 h not evaluated
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: time point 72 h not evaluated
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days, necrosis at day 8, score: 4
Remarks on result:
other: overlapping (d1, 2), spotted (d2); time point 72 h not evaluated
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: overlapping, spotted (d1, 2); time point 72 h not evaluated
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days; necrosis, score: 4.
Remarks on result:
other: overlapping (d1), necrosis (d2); time point 72 h not evaluated
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: time point 72 h not evaluated
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: time point 72 h not evaluated
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: time point 72 h not evaluated
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: overlapping (d1, 2); time point 72 h not evaluated
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: overlapping (d1, 2); time point 72 h not evaluated
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: overlapping (d1, 2); time point 72 h not evaluated
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: time point 72 h not evaluated
Irritant / corrosive response data:
Necrosis was observed in 3 out of 6 animals after 8 days, in the remaining animals the conditions were fully reversible within 8 days

Applicant's summary and conclusion